Eye Injections of Bevacizumab to See if Medication Helps to Lower Risk of Scar Tissue Development in the Retina and Repeated Retinal Detachment.

Retinal Detachment Clinical Trial

Official title:

A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01860586
• Other study ID #: HsuPVR13
• Secondary ID: MARPVR2013
• Status: Active, not recruiting
• Phase: N/A
• First received: May 20, 2013
• Last updated: September 30, 2014
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: September 2014
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on the rates of recurrent retinal detachment and scar tissue formation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Undergoing pars plana vitrectomy with or without scleral buckling for recurrent RD due to PVR with planned silicone oil instillation.

Exclusion Criteria:

• Prior anti-VEGF (vascular endothelial growth factor) injections within 3 months of retinal detachment surgery.

• Traction retinal detachment due to proliferative diabetic retinopathy.

• Inability to flatten retina completely intraoperatively

• Known allergy or contraindication to intravitreal bevacizumab

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Vitreoretinopathy Proliferative

Intervention

Drug:
• Bevacizumab
.005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intravitreal bevacizumab injections impact on visual acuity score (change in letters read).	Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.	6 months	No
Primary	The effect of intravitreal bevacizumab injections on retinal detachment rate (increase or decrease)	This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.	up to 6 months	No
Secondary	The effect of intravitreal bevacizumab injections on the development of recurrent Proliferative vitreoretinopathy (PVR).	To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of recurrent PVR .	6 months	No